Acupuncture for Patients With Chronic Tension-type Headache

Overview

Two hundred and eighteen patients with chronic tension-type headache(CTTH) will be randomly assigned to an experimental group (acupuncture) and a control group (superficial acupuncture) in a 1:1 ratio. Participants in both groups will receive 20 sessions of acupuncture over 8 weeks, and the same acupoints will be selected in acupuncture treatments.The study cycle will last 36 weeks, including a 4-week baseline period, a 8-week treatment period and a 24-week follow-up period. And the primary outcome will be measured at the end of 16th week. While, the secondary outcomes will be measured at the baseline, the 4th, 8th,12th,16th,20th,24th,28th and 32nd week after randomization.After each treatment, participants will finish the Massachusetts General Hospital (MGH) Acupuncture Sensation Scale (MASS) to evaluate deqi sensations.

Full Title of Study: “Acupuncture for Patients With Chronic Tension-type Headache : a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2019

Detailed Description

This is a clinical randomized controlled trial (RCT). According to the pervious study, 218 patients, who meet the diagnostic criteria of CTTH in the international classification of headache disorders, 3rd edition (beta version) (ICHD-III beta), will be recruited in this study. And these participants will be randomly assigned to 2groups with acupuncture treatment or superficial acupuncture treatment through central randomization in a 1:1 ratio. The total observation period will last 36 weeks, including a 4-week baseline period, a 8-week treatment period and a 24-week follow-up period. The central randomization will be performed after the baseline period, and participants will receive 20 sessions of intervention over 8 weeks ( 3 sessions per week in the first 4 weeks and 2 sessions per week in the following 4 weeks). The same acupoints, named Fengchi (GB20), Taiyang (EX-HN5), Baihui (DU20), Hegu (LI4) and Taichong (LR3) on both sides, will be punctured by filiform needles. However, manipulation methods will be different. In acupuncture group, the needles will be inserted into the acupoints, of which the depths will be adjusted to the standard permissible layers.Then even reinforcing-reducing technique will be performed on the needles until achieving deqi sensation.The needles will be retained for 30 minutes in each session and manipulated twice every 10 minutes with intermittent stimulation. Each manipulation will last for 30 seconds. While, in superficial group, the selected acupoints will be punctured superficially by the depth of 1-3 mm, and the needles will be retained for 30 minutes without any manipulation. Within 5 minutes after withdrawing needles of each session, participants in three acupuncture groups will finish the Massachusetts General Hospital (MGH) Acupuncture Sensation Scale (MASS). Most of the curative outcomes will be collected from the headache dairy which is filled by participants. And the primary outcome will be measured at the end of 16th week. While, the secondary outcomes will be measured at the baseline, the 4th, 8th,12th,16th,20th,24th,28th and 32nd week after randomization.

Interventions

  • Other: acupuncture
    • The needles will be inserted into the acupoints and the depths will be adjusted to the standard permissible layers, then even reinforcing-reducing technique will be performed on the needles until achieving deqi sensation.The needles will be retained for 30 minutes in each session and manipulated twice every 10 minutes with intermittent stimulation. Each manipulation will last for 30 seconds.
  • Other: superficial acupuncture
    • The selected acupoints will be punctured superficially by the depth of 1-3 mm, and the needles will be retained for 30 minutes without any manipulation.

Arms, Groups and Cohorts

  • Experimental: Acupuncture
    • The needles will be inserted into the acupoints and the depths will be adjusted to the standard permissible layers, then even reinforcing-reducing technique will be performed on the needles until achieving deqi sensation.The needles will be retained for 30 minutes in each session and manipulated twice every 10 minutes with intermittent stimulation. Each manipulation will last for 20 seconds.
  • Other: Superficial acupuncture
    • The selected acupoints will be punctured superficially by the depth of 1-3 mm, and the needles will be retained for 30 minutes without any manipulation.

Clinical Trial Outcome Measures

Primary Measures

  • Responder rate
    • Time Frame: 16 weeks after randomization
    • The responder rate is defined as >50% reduction in the number of headache days per four week

Secondary Measures

  • The number of days with headache
    • Time Frame: at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization
  • The mean pain intensity of tension-type headache during 4 weeks
    • Time Frame: at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization
    • Using a visual analogue scale from 0-10, 0 defined as no pain and 10 defined as an unbearable pain.
  • The rate of medication intake during 4 weeks
    • Time Frame: at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization
  • Evaluation of quality of life
    • Time Frame: at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization
    • The 36-item short from health survey (SF-36)
  • Evaluation of anxiety state
    • Time Frame: at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization
    • Hamilton anxiety scale (HAMA)
  • Evaluation of depression state
    • Time Frame: at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization
    • Hamilton depression scale (HAMD)
  • Evaluation of needling sensation
    • Time Frame: Within 5 minutes after withdrawing needles of each acupuncture session
    • the Massachusetts General Hospital (MGH) Acupuncture Sensation Scale (MASS)

Participating in This Clinical Trial

Inclusion Criteria

1. Meeting the diagnostic criteria of CTTH in the international classification of headache disorders, 3rd edition (beta version) (ICHD-III beta); 2. Aged 18-65 years; 3. Having the ability of understanding and completing the headache dairy; 4. Volunteering to this study and able to provide written informed consent. Exclusion Criteria:

1. Not suffering tension-type headache during the pervious 3 months; 2. Taking any prophylactic headache medication during the previous one month; 3. Headache due to organic disorders (e.g. subarachnoid hemorrhage, cerebral hemorrhage, cerebral embolism, cerebral thrombosis, vascular malformation, arthritis, hypertension, arteriosclerosis); 4. Having serious diseases of the heart, liver, kidney or other organs; 5. In pregnancy or lactation, or planning to be pregnant in 6 months; 6. In unconsciousness, or having psychosis; 7. Having bleeding disorders or getting infectious; 8. Unwilling to take parts in this study or with low compliance; 9. Addicted to smoking, alcohol or drugs; 10. Taking parts in other clinical studies at the same time.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chengdu University of Traditional Chinese Medicine
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ying Li, PhD, Study Chair, Chengdu University of Traditional Chinese Medicine

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.